NCT04438655 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

American College of Surgeons
National Surgical Quality Improvement Program Semi-annual report. 2009. Available at: https://acsnsqip.org/login/default.aspx.
Arriaga AF, Lancaster RT, Berry WR, Regenbogen SE, Lipsitz SR, Kaafarani HM, Elbardissi AW, Desai P, Ferzoco SJ, Bleday R, Breen E, Kastrinakis WV, Rubin MS, Gawande AA
The better colectomy project: association of evidence-based best-practice adherence rates to outcomes in colorectal surgery. Ann Surg. 2009 Oct;250(4):507-13. doi: 10.1097/SLA.0b013e3181b672bc.
Csikesz NG, Nguyen LN, Tseng JF, Shah SA
Nationwide volume and mortality after elective surgery in cirrhotic patients. J Am Coll Surg. 2009 Jan;208(1):96-103. doi: 10.1016/j.jamcollsurg.2008.09.006. Epub 2008 Oct 31.
Finlayson EV, Goodney PP, Birkmeyer JD
Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg. 2003 Jul;138(7):721-5; discussion 726. doi: 10.1001/archsurg.138.7.721.
Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM
Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.
Slim K, Vicaut E, Launay-Savary MV, Contant C, Chipponi J
Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery. Ann Surg. 2009 Feb;249(2):203-9. doi: 10.1097/SLA.0b013e318193425a.

Prospective Randomized Clinical Trial on Oral and Intravenous Antibiotic Prophylaxis in Colorectal Surgery (COLORAL1).

Clinical trial NCT04438655 - References